Comparison of Nutritional Products for People With Type 2 Diabetes
July 29, 2010 updated by: Abbott Nutrition
Compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Malaga, Spain, 29010
- Hospital Universitario Virgen de la Victoria
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Zaragoza, Spain, 50009
- Hospital Universitario Miguel Servet
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months).
- Subject is between 18 and 75 years of age, inclusive.
- Subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit.
- If female is of childbearing potential, is practicing a method of birth control.
- Subject's BMI is > 18.5 kg/m2 and < 35 kg/m2.
- If on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit.
Exclusion Criteria:
- Subject uses exogenous insulin for glucose control.
- Subject states that he/she has type 1 diabetes.
- Subject states that he/she has a history of diabetic ketoacidosis.
- Subject takes an alpha-glucosidase inhibitor.
- Subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- Subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix).
- Subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- Subject states that he/she has end stage organ failure or is status post organ transplant.
- Subject states that he/she has a history of renal disease.
- Subject states that he/she has current hepatic disease.
- Subject states that he/she has a history of severe gastroparesis.
- Subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- Subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose.
- Subject states that he/she has clotting or bleeding disorders.
- Subject is known to be allergic or intolerant to any ingredient found in the study products.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: standard nutritional product
Standard nutritional product not specific for diabetes
|
once during crossover
|
|
Active Comparator: diabetes specific product
Diabetes specific nutritional product
|
once during crossover
|
|
Experimental: Experimental diabetes specific product
Diabetes specific experimental nutritional product
|
once during crossover
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the postprandial glycemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Time Frame: Three crossover periods
|
Three crossover periods
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To compare the postprandial insulinemic response of patients with type 2 diabetes consuming single servings of a standard liquid nutrition product and two diabetes-specific liquid nutrition products.
Time Frame: Three crossover periods
|
Three crossover periods
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jennifer Williams, MS, Abbott Nutrition
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
November 23, 2008
First Submitted That Met QC Criteria
November 24, 2008
First Posted (Estimate)
November 25, 2008
Study Record Updates
Last Update Posted (Estimate)
July 30, 2010
Last Update Submitted That Met QC Criteria
July 29, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.